exploratory study of irinotecan liposomes in maintenance therapy of metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: to evaluate the progression-free survival (pfs1), objective response rate (orr), disease control rate (dcr), progression-free survival from first-line treatment initiation (pfs2), overall survival (os), and safety of irinotecan liposome combined with bevacizumab in patients with advanced metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: * 18\~85 years old. * histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma. * pmmr or mss. * cr, pr, or sd (according to recist v1.1 criteria) achieved after 12-16 weeks of intensive treatment with a first-line chemotherapy regimen containing irinotecan/fluorouracil or a three-drug chemotherapy regimen containing oxaliplatin/irinotecan/fluorouracil plus bevacizumab. * if previously received neoadjuvant or adjuvant therapy, the time interval between initiation of systemic first-line therapy and the date of last dosing must be at least 6 months. * ecog 0\~1, patients ≥75 years old need an ecog score of 0. * normal bone marrow and organ function: ① neutrophils (anc) ≥1.5×10\^9/l, platelets (plt) ≥75×10\^9/l, hemoglobin (hb) ≥85g/l, albumin (alb) ≥30 g/l, white blood cells (wbc) ≥3.0×10\^9/l, and no bleeding tendency; ② ast, alt and alkaline phosphatase (alp) were all ≤2.5× upper limit of normal range (uln), and ≤5×uln when liver metastases occurred; the total bilirubin level doesn't exceed the upper limit of the agency's normal range; serum creatinine (cr) ≤1.5×uln or creatinine clearance ≥60 ml/min (calculated according to cockroft-gault). * understand the situation of this study, patients and/or legal representatives voluntarily agree to participate in this study and sign informed consent form. exclusion criteria: * known or suspected central nervous system metastasis. * had received surgery or other treatment for tumors other than intensive treatment (including chemotherapy, radiotherapy, research treatment, etc., within 4 weeks prior to enrollment, if the interval between the current treatment was longer than 5 drug half-lives, could be included). * previous treatment-related toxicity did not return to nci-ctcae v5.0 i or below (except for alopecia, peripheral neuropathy). * the use of cyp3a, cyp2c8, and ugt1a1 inhibitors or inducers couldn't be discontinued or were not discontinued within 2 weeks prior to enrollment. * the presence of severe gastrointestinal dysfunction or gastrointestinal perforation, intraperitoneal abscess, and fistula. * intestinal obstruction, signs and symptoms of intestinal obstruction, or the stent has been previously implanted and the stent has not been removed before the screening period. * interstitial lung disease. * tendency of arterial embolism and massive bleeding within 6 months before enrollment (except surgical bleeding). * patients with fluid accumulation that couldn't reach a stable state but small amount of ascites on imaging without clinical symptoms could be enrolled. * any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, heart disease, active bleeding, active viral infection, etc. * have had other malignancies within the past 5 years or currently, except cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancer. * patients of childbearing age who refuse to take contraceptives, women who are pregnant or breastfeeding. * the researchers didn't consider it appropriate to participate in this study.